The final risk enumeration defines the conclusive risk determination for each Risk Record after all risk controls and benefit-risk analysis are complete.
ISO 14971:2019 Clause 8.3 requires that the overall residual risk be evaluated and a final acceptability determination be made for each identified risk. The final risk field is the formal record of that determination.
The final risk enum deliberately excludes the Investigation option present in the pre/post-risk enum. This three-state model forces a definitive conclusion:
Risk Stage
Available States
Includes Investigation?
Pre-mitigation (preRisk)
Acceptable, Investigation, Unacceptable
Yes
Post-mitigation (postRisk)
Acceptable, Investigation, Unacceptable
Yes
Final risk (finalRisk)
Acceptable, Benefit-Risk Acceptable, Unacceptable
No
The transition from a three-state model (with Investigation) to a three-state model (without Investigation but with Benefit-Risk Acceptable) reflects the ISO 14971 requirement that every risk must reach a conclusive determination.
The final risk is automatically computed by the riskValueFinal() JavaScript function in the HARA risksheet top panel. The decision tree is:
The formula requires additionalControlsPossible to be explicitly set to "no" before the benefit-risk path is considered. If this field is empty or set to “yes”, the final risk defaults to Unacceptable — even if a valid benefit-risk justification exists. This is intentional: it forces teams to confirm that all practicable risk reduction has been exhausted.
The ISO 14971 HARA Report (Section 4 and Section 7) displays final risk statistics as dashboard-style summary cards:
Final Risk
Meaning in Report
Acceptable
Risk records with all risks reduced to tolerable levels
Benefit-Risk Acceptable
Risk records accepted through documented benefit-risk justification
Unacceptable
Risk records requiring further action before device release
Any Risk Record with a final risk of Unacceptable represents a blocking issue for device approval. The ISO 14971 HARA Report will flag these with a danger alert box, referencing ISO 14971 Clause 7.4 requirements for further risk reduction.
